Temporomandibular Disorders (TMD)Phase 4NCT07020455
Is the Combine Prolotherapy More Effective Than the Traditional Prolotherapy in Patients With Temporomandibular Joint Hypermobility?
A Phase 4 study testing prolotherapy solution of 20% dextrose and Arthrocentesis with ringer solution in people with Temporomandibular Disorders (TMD) and Temporomandibular Pain, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
1. Diagnosis and Indication You have been diagnosed with temporomandibular joint (TMJ) hypermobility and/or dysfunction, characterized by symptoms such as jaw clicking, locking, pain in the joint area, or difficulty in opening and closing the mouth. Read more about this study
- Who is it for?
- Ages 17 to 46 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Temporomandibular Pain, Hypermobility Syndrome (Disorder)
- What is being tested?
- prolotherapy solution of 20% dextrose and Arthrocentesis with ringer solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 46 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with unilateral or bilateral TMJ hypermobility
- history of open locking
- complaints of joint sounds and facial pain
- treated with combine or traditionally prolotherapy
- followed for at least 3 months
- the diagnosis of the patients was confirmed by TMJ radiography
Who cannot join
- patients who underwent discectomy
- patients with active infection (fever, redness, oedema, loss of function, etc.)
- pathological findings (tumour, cyst, etc.) in the related area were excluded
- patients with systemic disorders that could affect the results
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Trabzon, 61040
About this study
Official title: Is The Combine Prolotherapy More Effective Than The Traditional Prolotherapy In Patients With Temporomandibular Joint Hypermobility?
- Diagnosis and Indication You have been diagnosed with temporomandibular joint (TMJ) hypermobility and/or dysfunction, characterized by symptoms such as jaw clicking, locking, pain in the joint area, or difficulty in opening and closing the mouth. After clinical and radiographic evaluation, the recommended treatment includes arthrocentesis and prolotherapy, either alone or in combination.
- Description of Procedures
- TMJ Arthrocentesis: This is a minimally invasive procedure in which small needles are inserted into the TMJ space to irrigate the joint using sterile fluid (e.g., Ringer's solution). The procedure aims to eliminate inflammatory mediators, release joint adhesions, and improve mandibular mobility. It is generally performed under local anesthesia in an outpatient setting.
- Prolotherapy: Prolotherapy involves the injection of an irritant solution (typically dextrose combined with a local anesthetic) into the joint capsule, ligaments, or surrounding tissue. The goal is to stimulate the body's natural healing response, promoting collagen production and tissue regeneration to improve joint stability and function.
- Combined Approach: In certain cases, both treatments may be performed during the same session to maximize clinical benefit-arthrocentesis addresses inflammation and mobility, while prolotherapy enhances long-term stabilization.
- Benefits and Expected Outcomes Reduction in TMJ pain and joint clicking Improved jaw function and range of motion Stabilization of the joint and reduced recurrence of dislocation or subluxation Minimally invasive and generally well-tolerated
- Possible Risks and Complications Although these procedures are generally safe, potential risks may include but are not limited to: Mild pain or swelling at the injection site Temporary facial numbness or weakness (rare and usually self-resolving) Dizziness or light-headedness Joint stiffness or infection (very rare) Allergic reaction to anesthetic or injected substances
- Alternatives to the Proposed Procedure You have the right to consider other treatment options, which may include: Physical therapy or jaw exercises Oral splints or bite guards Medication (analgesics, muscle relaxants) Surgical interventions (if conservative methods fail)
- Patient Instructions and Post-Procedure Care Avoid wide mouth opening, yawning, or chewing hard foods for several days
Use only recommended medications (e.g., acetaminophen/paracetamol); avoid anti-inflammatory drugs unless advised otherwise
Read more
Apply cold compresses to reduce swelling if necessary
Attend all scheduled follow-up appointments
Notify your doctor immediately if you experience severe pain, prolonged numbness, fever, or signs of infection
- Conditions
- Temporomandibular Disorders (TMD), Temporomandibular Pain, Hypermobility Syndrome (Disorder), Hypermobility, Joint, Arthrocentesis, Prolotherapy
- Being tested
- prolotherapy solution of 20% dextrose, Arthrocentesis with ringer solution
- Keywords
- hypermobility, subluxation, prolotherapy, arthrocentesis
- Medical subject headings
- Temporomandibular Joint Disorders, Joint Instability, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prolotherapy solution of 20% dextroseDrug
Polotherapy, it involves injecting an irritant solution into weakened joints, ligaments, or tendons to stimulate collagen production and tissue repair at fibro-osseous junctions.
Arthrocentesis with ringer solutionDrug
Integrating arthrocentesis with prolotherapy may enhance therapeutic outcomes by addressing both the mechanical and inflammatory aspects of TMJ hypermobility. This dual-modality technique presents a promising minimally invasive option for clinicians managing patients with joint instability.
| Study group | Role | What they receive |
|---|---|---|
| Combined Prolotherapy Group | Experimental | Patients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy. Receives: Drug: prolotherapy solution of 20% dextrose; Drug: Arthrocentesis with ringer solution |
| Traditional Prolotherapy Group | Active comparator | Prolotherapy was applied to patients with TMJ hypermobility. Receives: Drug: prolotherapy solution of 20% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity of TMJ
Pain intensity of TMJ evaluated by visual analog scale (VAS) questionnaire. VAS is designated by an marked horizontal line, 10 mm long, scored from 0 (no pain) to 10 (intolerable pain), anchored by word identifiers at each end. Patients marked the point on the line that they thought represented their current situation.
Measured: From pre-treatment to the 3rd month after treatment
Secondary outcomes (1)
Maximal interincisal opening (MIO)
Maximal interincisal opening (MIO) was recorded by measuring the distance between the incisal edges of the upper and lower incisors in the midline with the help of a ruler. Maximal interincisal opening was measured preoperatively (T0), postoperatively 1 week (T1), 1 month (T2) and 3 months (T3).
Measured: From pre-treatment to the 3rd month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The first group applied prolotherapy, while the other group applied arthrocentesis and prolotherapy together.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Ateş, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020455
- Sponsor's protocol ID
- 2025/6
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Comert Kilic S, Gungormus M. Is dextrose prolotherapy superior to placebo for the treatment of temporomandibular joint hypermobility? A randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Jul;45(7):813-9. doi: 10.1016/j.ijom.2016.01.006. Epub 2016 Feb 2.
PubMed 26846795Dasukil S, Shetty SK, Arora G, Degala S. Efficacy of Prolotherapy in Temporomandibular Joint Disorders: An Exploratory Study. J Maxillofac Oral Surg. 2021 Mar;20(1):115-120. doi: 10.1007/s12663-020-01328-9. Epub 2020 Jan 13.
PubMed 33584052Taskesen F, Cezairli B. Efficacy of prolotherapy and arthrocentesis in management of temporomandibular joint hypermobility. Cranio. 2023 Sep;41(5):423-431. doi: 10.1080/08869634.2020.1861887. Epub 2020 Dec 16.
PubMed 33326351Cezairli B, Sivrikaya EC, Omezli MM, Ayranci F, Seyhan Cezairli N. Results of Combined, Single-Session Arthrocentesis and Dextrose Prolotherapy for Symptomatic Temporomandibular Joint Syndrome: A Case Series. J Altern Complement Med. 2017 Oct;23(10):771-777. doi: 10.1089/acm.2017.0068. Epub 2017 Oct 10.
PubMed 29017019Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.
PubMed 36523721Dagenais S, Wooley J, Hite M, Green R, Mayer J. Acute toxicity evaluation of proliferol: a dose-escalating, placebo-controlled study in swine. Int J Toxicol. 2009 May-Jun;28(3):219-29. doi: 10.1177/1091581809336478.
PubMed 19546260Refai H. Long-term therapeutic effects of dextrose prolotherapy in patients with hypermobility of the temporomandibular joint: a single-arm study with 1-4 years' follow up. Br J Oral Maxillofac Surg. 2017 Jun;55(5):465-470. doi: 10.1016/j.bjoms.2016.12.002. Epub 2017 Apr 29.
PubMed 28460873Gibaly A, Abdelmoiz M, Alghandour AN. Evaluation of the effect of dextrose prolotherapy versus deep dry needling therapy for the treatment of temporomandibular joint anterior disc displacement with reduction: (a randomized controlled trial). Clin Oral Investig. 2024 Aug 8;28(9):475. doi: 10.1007/s00784-024-05830-z.
PubMed 39115583Zhou H, Hu K, Ding Y. Modified dextrose prolotherapy for recurrent temporomandibular joint dislocation. Br J Oral Maxillofac Surg. 2014 Jan;52(1):63-6. doi: 10.1016/j.bjoms.2013.08.018. Epub 2013 Sep 21.
PubMed 24064304Ungor C, Atasoy KT, Taskesen F, Cezairli B, Dayisoylu EH, Tosun E, Senel FC. Short-term results of prolotherapy in the management of temporomandibular joint dislocation. J Craniofac Surg. 2013 Mar;24(2):411-5. doi: 10.1097/SCS.0b013e31827ff14f.
PubMed 23524704Nagori SA, Jose A, Gopalakrishnan V, Roy ID, Chattopadhyay PK, Roychoudhury A. The efficacy of dextrose prolotherapy over placebo for temporomandibular joint hypermobility: A systematic review and meta-analysis. J Oral Rehabil. 2018 Dec;45(12):998-1006. doi: 10.1111/joor.12698. Epub 2018 Aug 3.
PubMed 30024045Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
PubMed 19875361Distel LM, Best TM. Prolotherapy: a clinical review of its role in treating chronic musculoskeletal pain. PM R. 2011 Jun;3(6 Suppl 1):S78-81. doi: 10.1016/j.pmrj.2011.04.003.
PubMed 21703585Nitzan DW, Dolwick MF, Martinez GA. Temporomandibular joint arthrocentesis: a simplified treatment for severe, limited mouth opening. J Oral Maxillofac Surg. 1991 Nov;49(11):1163-7; discussion 1168-70. doi: 10.1016/0278-2391(91)90409-f.
PubMed 1941330Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013.
PubMed 20188998
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is The Combine Prolotherapy More Effective Than The Traditional Prolotherapy In Patients With Temporomandibular Joint Hypermobility?
- ClinicalTrials.gov ID
- NCT07020455
- Acronym / sponsor ID
- 2025/6
- Conditions
- Temporomandibular Disorders (TMD), Temporomandibular Pain, Hypermobility Syndrome (Disorder), Hypermobility, Joint, Arthrocentesis, Prolotherapy
- Keywords
- hypermobility, subluxation, prolotherapy, arthrocentesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Diagnosis and Indication You have been diagnosed with temporomandibular joint (TMJ) hypermobility and/or dysfunction, characterized by symptoms such as jaw clicking, locking, pain in the joint area, or difficulty in opening and closing the mouth. After clinical and radiographic evaluation, the recommended treatment includes arthrocentesis and prolotherapy, either alone or in combination.
- Description of Procedures
- TMJ Arthrocentesis: This is a minimally invasive procedure in which small needles are inserted into the TMJ space to irrigate the joint using sterile fluid (e.g., Ringer's solution). The procedure aims to eliminate inflammatory mediators, release joint adhesions, and improve mandibular mobility. It is generally performed under local anesthesia in an outpatient setting.
- Prolotherapy: Prolotherapy involves the injection of an irritant solution (typically dextrose combined with a local anesthetic) into the joint capsule, ligaments, or surrounding tissue. The goal is to stimulate the body's natural healing response, promoting collagen production and tissue regeneration to improve joint stability and function.
- Combined Approach: In certain cases, both treatments may be performed during the same session to maximize clinical benefit-arthrocentesis addresses inflammation and mobility, while prolotherapy enhances long-term stabilization.
- Benefits and Expected Outcomes Reduction in TMJ pain and joint clicking Improved jaw function and range of motion Stabilization of the joint and reduced recurrence of dislocation or subluxation Minimally invasive and generally well-tolerated
- Possible Risks and Complications Although these procedures are generally safe, potential risks may include but are not limited to: Mild pain or swelling at the injection site Temporary facial numbness or weakness (rare and usually self-resolving) Dizziness or light-headedness Joint stiffness or infection (very rare) Allergic reaction to anesthetic or injected substances
- Alternatives to the Proposed Procedure You have the right to consider other treatment options, which may include: Physical therapy or jaw exercises Oral splints or bite guards Medication (analgesics, muscle relaxants) Surgical interventions (if conservative methods fail)
- Patient Instructions and Post-Procedure Care Avoid wide mouth opening, yawning, or chewing hard foods for several days
Use only recommended medications (e.g., acetaminophen/paracetamol); avoid anti-inflammatory drugs unless advised otherwise
Apply cold compresses to reduce swelling if necessary
Attend all scheduled follow-up appointments
Notify your doctor immediately if you experience severe pain, prolonged numbness, fever, or signs of infection
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The first group applied prolotherapy, while the other group applied arthrocentesis and prolotherapy together.
| Arm | Type | Receives |
|---|---|---|
| Combined Prolotherapy Group | Experimental | Drug: prolotherapy solution of 20% dextrose, Drug: Arthrocentesis with ringer solutionPatients with TMJ hypermobility underwent arthrocentesis for joint pain in addition to prolotherapy. |
| Traditional Prolotherapy Group | Active comparator | Drug: prolotherapy solution of 20% dextroseProlotherapy was applied to patients with TMJ hypermobility. |
Who may qualify
- Ages
- 17 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- patients with unilateral or bilateral TMJ hypermobility
- history of open locking
- complaints of joint sounds and facial pain
- treated with combine or traditionally prolotherapy
- followed for at least 3 months
Key exclusion criteria (4 listed)
- patients who underwent discectomy
- patients with active infection (fever, redness, oedema, loss of function, etc.)
- pathological findings (tumour, cyst, etc.) in the related area were excluded
- patients with systemic disorders that could affect the results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prolotherapy solution of 20% dextrosePolotherapy, it involves injecting an irritant solution into weakened joints, ligaments, or tendons to stimulate collagen production and tissue repair at fibro-osseous junctions. | Drug | Combined Prolotherapy Group, Traditional Prolotherapy Group |
| Arthrocentesis with ringer solutionIntegrating arthrocentesis with prolotherapy may enhance therapeutic outcomes by addressing both the mechanical and inflammatory aspects of TMJ hypermobility. This dual-modality technique presents a promising minimally invasive option for clinicians managing patients with joint instability. | Drug | Combined Prolotherapy Group |
Primary outcome
Pain intensity of TMJ
Time frame: From pre-treatment to the 3rd month after treatment
Pain intensity of TMJ evaluated by visual analog scale (VAS) questionnaire. VAS is designated by an marked horizontal line, 10 mm long, scored from 0 (no pain) to 10 (intolerable pain), anchored by word identifiers at each end. Patients marked the point on the line that they thought represented their current situation.
1 secondary outcome
Maximal interincisal opening (MIO)
Time frame: From pre-treatment to the 3rd month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Results publication: PubMed 26846795Comert Kilic S, Gungormus M. Is dextrose prolotherapy superior to placebo for the treatment of temporomandibular joint hypermobility? A randomized clinical trial. Int J Oral Maxillofac Surg. 2016 Jul;45(7):813-9. doi: 10.1016/j.ijom.2016.01.006. Epub 2016 Feb 2.
- Results publication: PubMed 33584052Dasukil S, Shetty SK, Arora G, Degala S. Efficacy of Prolotherapy in Temporomandibular Joint Disorders: An Exploratory Study. J Maxillofac Oral Surg. 2021 Mar;20(1):115-120. doi: 10.1007/s12663-020-01328-9. Epub 2020 Jan 13.
- Results publication: PubMed 33326351Taskesen F, Cezairli B. Efficacy of prolotherapy and arthrocentesis in management of temporomandibular joint hypermobility. Cranio. 2023 Sep;41(5):423-431. doi: 10.1080/08869634.2020.1861887. Epub 2020 Dec 16.
- Results publication: PubMed 29017019Cezairli B, Sivrikaya EC, Omezli MM, Ayranci F, Seyhan Cezairli N. Results of Combined, Single-Session Arthrocentesis and Dextrose Prolotherapy for Symptomatic Temporomandibular Joint Syndrome: A Case Series. J Altern Complement Med. 2017 Oct;23(10):771-777. doi: 10.1089/acm.2017.0068. Epub 2017 Oct 10.
- Results publication: PubMed 36523721Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.
- Results publication: PubMed 19546260Dagenais S, Wooley J, Hite M, Green R, Mayer J. Acute toxicity evaluation of proliferol: a dose-escalating, placebo-controlled study in swine. Int J Toxicol. 2009 May-Jun;28(3):219-29. doi: 10.1177/1091581809336478.
- Results publication: PubMed 28460873Refai H. Long-term therapeutic effects of dextrose prolotherapy in patients with hypermobility of the temporomandibular joint: a single-arm study with 1-4 years' follow up. Br J Oral Maxillofac Surg. 2017 Jun;55(5):465-470. doi: 10.1016/j.bjoms.2016.12.002. Epub 2017 Apr 29.
- Results publication: PubMed 39115583Gibaly A, Abdelmoiz M, Alghandour AN. Evaluation of the effect of dextrose prolotherapy versus deep dry needling therapy for the treatment of temporomandibular joint anterior disc displacement with reduction: (a randomized controlled trial). Clin Oral Investig. 2024 Aug 8;28(9):475. doi: 10.1007/s00784-024-05830-z.
- Results publication: PubMed 24064304Zhou H, Hu K, Ding Y. Modified dextrose prolotherapy for recurrent temporomandibular joint dislocation. Br J Oral Maxillofac Surg. 2014 Jan;52(1):63-6. doi: 10.1016/j.bjoms.2013.08.018. Epub 2013 Sep 21.
- Results publication: PubMed 23524704Ungor C, Atasoy KT, Taskesen F, Cezairli B, Dayisoylu EH, Tosun E, Senel FC. Short-term results of prolotherapy in the management of temporomandibular joint dislocation. J Craniofac Surg. 2013 Mar;24(2):411-5. doi: 10.1097/SCS.0b013e31827ff14f.
- Results publication: PubMed 30024045Nagori SA, Jose A, Gopalakrishnan V, Roy ID, Chattopadhyay PK, Roychoudhury A. The efficacy of dextrose prolotherapy over placebo for temporomandibular joint hypermobility: A systematic review and meta-analysis. J Oral Rehabil. 2018 Dec;45(12):998-1006. doi: 10.1111/joor.12698. Epub 2018 Aug 3.
- Results publication: PubMed 19875361Foster TE, Puskas BL, Mandelbaum BR, Gerhardt MB, Rodeo SA. Platelet-rich plasma: from basic science to clinical applications. Am J Sports Med. 2009 Nov;37(11):2259-72. doi: 10.1177/0363546509349921.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prolotherapy solution of 20% dextrose and Arthrocentesis with ringer solution in people with Temporomandibular Disorders (TMD) and Temporomandibular Pain, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity of TMJ (time frame: From pre-treatment to the 3rd month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07020455, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.